Northwest Iowa Urologists, Pc

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the Qualigen calibration verification records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 3:30 pm on 03/28/2022, the laboratory failed to perform prostatic specific antigen (PSA) and testosterone calibration verifications every six months for two out of three time periods from 1/1/2021 - 3/28/2022 on the Qualigen test system. The findings include: 1. The laboratory performed PSA and testosterone calibration Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- verifications for the Qualigen test system on 1/1/2021. 2. The laboratory did not perform any additional PSA or testosterone calibration verifications after 1/1/2021. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observations made during the survey, Qualigen test records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 3:30 pm on 03/28/2022, the laboratory failed to perform prostatic specific antigen (PSA) comparison testing twice annually for one out of three semiannual time periods from 1/1/2021 - 3/28/2022. The findings include: 1. The laboratory performed PSA testing using Qualigen analyzers 0334 and 0935. 2. The laboratory performed PSA comparison testing between the two analyzers on 2/25 /2021 and 2/1/2022. 3. The laboratory did not perform PSA comparison for the time period between 2/25/2021 and 2/1/2022. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and confirmed by laboratory personnel identifier # 2 (refer to the Laboratory Personnel Report) at approximately 3:30 pm on 01/17/2018, the laboratory failed to maintain a copy of the PT attestation statement signed by the laboratory director and testing personnel for two out of six PT testing events (2016 Hematology/Coagulation events 2 and 3) in 2016-2017. At the time of the survey, the laboratory did not have attestation statements for 2016 Hematology/Coagulation PT testing events 2 and 3. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 4:00 pm on 01/17/2018, the laboratory failed to indicate positive patient identification for three out of three patient test reports (Patient identifiers A, B, and C). The findings include: 1. Patient identifier A had prostrate specific antigen (PSA) testing performed on 07/25 /2017. 2. Patient identifier B had PSA testing performed on 07/06/2017. 3. Patient identifier C had testosterone testing performed on 07/11/2017. 4. The test reports for patient identifiers A, B, and C all included the patients' names but did not include a second identification number or unique identifier. -- 2 of 2 --